Risk of adverse behavioral effects with pediatric use of antidepressants.

OBJECTIVES

This article reviews evidence that led the Food and Drug Administration to issue a "black box" warning about the risk of "suicidality" (suicidal thoughts and behavior) in children and adolescents during treatment with antidepressants.

RESULTS

Re-analysis of data from randomized clinical trials of antidepressants in the pediatric population revealed a significantly greater overall (all drugs across all indications) risk ratio for drug 1.95 (95% Cl, 1.28-2.98) compared to placebo in this sample of approximately 4,000 subjects.

DISCUSSION

The essential message of the "black box" is to remind prescribers and consumers about the importance of monitoring closely for adverse behavioral changes during the initiation of (or changes in) antidepressant therapy. Possible mechanisms that might account for this phenomenon, particularly the so-called activation syndrome, are discussed.

CONCLUSION

Empirical studies are needed to identify the precursors of suicidality and to predict which individuals are most susceptible to adverse behavioral side effects of antidepressants.